Manual disposable syringe based devices have existed since the mid-1800's. These devices were designed for a single purpose of performing a subcutaneous injection through a hollow-bore needle affixed to the syringe device. Syringes are simple mechanical systems with no capability of refined fluid dynamics or ability to integrate advanced digital capabilities.
A prefilled syringe is a primary drug container and delivery system for the administration of an injectable therapy by a healthcare worker or a patient. Prefilled syringes are typically supplied to pharmaceutical customers in a ready-to-fill format for filling and packaging with a measured dose of an injectable drug or vaccine. The primary container is compliant with industry standards and pharmacopeias to ensure protection of the drug formulation over a prolonged duration.
Auto-injectors are used for self-administration by the patient outside of the healthcare system. Auto-injectors are designed to allow operators to automatically deliver the contents of a prefilled syringe at the push of a button. The auto-injector market is one of the fastest-growing segments in the medical device market. Auto-injection or “pen” devices have recently become increasingly popular for single dose or multi dose, at home self-administration. These auto-injection devices are primarily designed to accomplish two basic objectives: convenience and automation of drug delivery in an outpatient setting. These are typically mechanically spring-loaded devices that advance a component of the device to transfer medication via hollow-bore needle to a patient's tissues.
Auto-injection devices are routinely used to provide a means for self-injecting certain medications. The size and operation of these auto-injection devices can often be daunting to a patient, whether they are injecting themselves for the first or they have injected themselves before. These fears and anxieties associated with the currently available self-injection devices, particularly the auto-injection devices, may result in the administration of an incomplete dose of a medicament, failure to administer any portion of the dose of a medicament, or accidentally sticking oneself with the needle of the device, which in some instances could lead to unwanted transmission of diseases if the needle is contaminated. Furthermore, oftentimes medications are wasted when an injection device is removed from the patient mid-way through an injection before an entire dose of medicament has been received by the patient. As a result, reduced therapy compliance is also a great concern with injection devices.
Auto-injection devices lack the ability to regulate whether the medication is actually delivered to the patient or whether it is delivered to a correct location. Most auto-injection devices fail to integrate advanced digital capabilities. Therefore, there exists a need for an injection device which may be safely and efficiently used by patients without medical experience in preparing and self-injecting medications and which increases therapy compliance.